August 16, 2011
By Thomas Varricchione, Senior Vice President, Clinical & Regulatory Affairs
The FDA recently issued guidance to clarify when modifications to a cleared device require a new application. The guidance, titled 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, requires that device makers demonstrate how a modified device is similar to the one already on the market.
Medical device manufacturers must file a new 510(k) only when the changes significantly impact a device’s safety and effectiveness or if the revision constitutes a new intended use. Many medical device products undergo incremental changes even after they are introduced into the market, and most of those changes do not require a new 510(k) submission. This is good news for device manufacturers who are concerned about delays in speed to market while striving to improve the use and safety of their products.
And while FDA was busy releasing guidance on modifications to medical devices, the Institute of Medicine (IOM) was releasing its recommendation on modifications to the 510(k) process.
“The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
A week later, the IOM clarified that it is not recommending a tougher pre-market bar for all class II devices. While FDA doesn’t believe the 510(k) program should be scrapped in its entirety, the agency is open to modifications that are “based on sound science and through thoughtful and transparent discussion.” FDA is now soliciting public comments on the IOM recommendations.
Changes to FDA’s premarket review procedures for medical devices is a hugely controversial topic in recent years, with divergent views being expressed by patient advocacy organizations, industry organizations, health care practitioners, “think tank’ organizations (such as the IOM), and by FDA itself. Bottom line, the Center for Devices and Radiological Health (CDRH) doesn’t have the resources to require that significantly more devices undergo a Premarket Approval review process. And to date, the de novo process for reclassifying new devices “failing” to be cleared through the 510(k) process has been deemed unsatisfactory by virtually all the stakeholders.
Regardless of the outcome, manufacturers need to continue advancing innovative medical product development leading to improved safety, usability, and effectiveness for patients and clinicians. If that goal is reached, the task of convincing regulators that a product belongs on the market becomes an educational process dependent on sound data presented in clear fashion.